Automatic selection of parameters of an exposure mode of an implantable medical device

ABSTRACT

An implantable medical device (IMD) automatically determines at least a portion of the parameters and, in some instances all of the parameters, of an exposure operating mode based on stored information regarding sensed physiological events or therapy provided over a predetermined period of time. The IMD may configure itself to operate in accordance with the automatically determined parameters of the exposure operating mode in response to detecting a disruptive energy field. Alternatively, the IMD may provide the automatically determined parameters of the exposure operating mode to a physician as suggested or recommended parameters for the exposure operating mode. In other instances, the automatically determined parameters may be compared to parameters received manually via telemetry and, if differences exist or occur, a physician or patient may be notified and/or the manual parameters may be overridden by the automatically determined parameters.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of U.S. patent application Ser. No.14/886,152, (U.S. Publication No. 2016/0038744), filed Oct. 19, 2015,which was a Division of U.S. patent application Ser. No. 12/569,101, nowU.S. Pat. No. 9,174,058, filed Sep. 29, 2009, the content of both ofwhich are incorporated herein by reference in their entirety.

TECHNICAL FIELD

The disclosure relates generally to implantable medical devices and, inparticular, to operation of an implantable medical device when exposedto a disruptive energy field.

BACKGROUND

A wide variety of implantable medical devices (IMDs) that deliver atherapy to or monitor a physiologic condition of a patient have beenclinically implanted or proposed for clinical implantation in patients.IMDs may deliver therapy or monitor conditions with respect to a varietyof organs, nerves, muscles or tissues of the patients, such as theheart, brain, stomach, spinal cord, pelvic floor or the like. In somecases, IMDs may deliver electrical stimulation therapy via one or moreelectrodes, which may be included as part of one or more elongatedimplantable medical leads.

For example, an implantable cardiac device, such as a cardiac pacemakeror implantable cardioverter-defibrillator, provides therapeuticstimulation to the heart by delivering electrical therapy signals suchas pulses or shocks for pacing, cardioversion, or defibrillation viaelectrodes of one or more implantable leads. As another example, aneurostimulator may deliver electrical therapy signals, such as pulses,to a spinal cord, brain, pelvic floor or the like, to alleviate pain ortreat symptoms of any of a number of neurological or other diseases,such as epilepsy, gastroparesis, Alzheimer's, depression, obesity,incontinence and the like.

Exposure of the IMD to a disruptive energy field may result in improperoperation of the IMD, damage to the IMD and/or damage to tissue adjacentto portions of the IMD. The IMD may be exposed to the disruptive energyfield for any of a number of reasons. For example, one or more medicalprocedures may need to be performed on the patient within which the IMDis implanted for purposes of diagnostics or therapy. For example, thepatient may need to have a magnetic resonance imaging (MRI) scan,computed tomography (CT) scan, electrocautery, diathermy or othermedical procedure that produces a magnetic field, electromagnetic field,electric field or other disruptive energy field.

The disruptive energy field may induce energy on one or more of theimplantable leads coupled to the IMD. The IMD may inappropriately detectthe induced energy on the leads as physiological signals. Alternatively,or additionally, the induced energy on the leads may result in theinability to correctly detect physiological signals. In either case,detection of the induced energy on the leads as physiological signalsmay result in the IMD delivering therapy when it is not desired orwithholding therapy when it is desired. In other instances, the inducedenergy on the leads may result in stimulation or heating of the tissueand/or nerve site adjacent to the electrodes of the leads or adjacent tothe housing of the IMD. Such heating may result in thermal damage to thetissue, thus compromising pacing and sensing thresholds at the site.

SUMMARY

In general, this disclosure relates to operation of an implantablemedical device (IMD) in a disruptive energy field. In particular, thisdisclosure describes techniques for automatically determining at least aportion of the parameters and, in some instances all of the parameters,of an exposure operating mode based on stored information regardingsensed physiological events or therapy provided over a predeterminedperiod of time. For example, the IMD may analyze parameters of therapy,if any, provided over the predetermined period of time, such as pacingmodes in which the device operated over the predetermined period oftime, amplitudes of the therapy energy delivered during thepredetermined period of time, pulse widths of the therapy energydelivered during the predetermined period of time, heart rate during thepredetermined period of time, or the like. Based on this analysis, thedevice may determine one or more parameters of the exposure operatingmode, such as a pacing mode and amplitude, pulse width, and/or rate ofthe therapy energy delivered during the exposure operating mode. The IMDmay automatically determine the parameters periodically ornon-periodically, e.g., in response to some input.

The IMD may configure itself to operate in accordance with theautomatically determined parameters of the exposure operating mode inresponse to detecting a disruptive energy field. Alternatively, the IMDmay provide the automatically determined parameters of the exposureoperating mode to a physician as suggested or recommended parameters forthe exposure operating mode. In other instances, the automaticallydetermined parameters may be compared to parameters received manuallyvia telemetry and, if any significant differences exist or occur, aphysician or patient may be notified and/or the manual parameters may beoverridden by the automatically determined parameters.

In one example, this disclosure is directed to an implantable medicaldevice comprising a memory and a processor that automatically determinesone or more parameters of an exposure operating mode based oninformation stored in the memory related to sensed physiological eventsor therapy provided over a predetermined period of time and switchesoperation of the implantable medical device from parameters of a currentoperating mode to the one or more automatically determined parameters ofthe exposure operating mode.

In another example, this disclosure is directed to a method comprisingautomatically determining, with an implantable medical device, one ormore parameters of an exposure operating mode based on storedinformation related to sensed physiological events or therapy providedover a predetermined period of time and switching operation of theimplantable medical device from parameters of a current operating modeto the one or more automatically determined parameters of the exposureoperating mode.

In a further example, this disclosure is directed to an implantablemedical device comprising means for automatically determining one ormore parameters of an exposure operating mode based on storedinformation related to sensed physiological events or therapy providedover a predetermined period of time and means for switching operation ofthe implantable medical device from parameters of a current operatingmode to the one or more automatically determined parameters of theexposure operating mode.

In another example, this disclosure is directed to a computer-readablemedium comprising instructions that, when executed, cause an implantablemedical device to automatically determine one or more parameters of anexposure operating mode based on stored information related to sensedphysiological events or therapy provided over a predetermined period oftime and switch operation of the implantable medical device fromparameters of a current operating mode to the one or more automaticallydetermined parameters of the exposure operating mode.

The details of one or more examples are set forth in the accompanyingdrawings and the description below. Other features, objects, andadvantages will be apparent from the description and drawings, and fromthe statements provided below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a conceptual diagram illustrating an environment in which animplantable medical device (IMD) is exposed to a disruptive energyfield.

FIG. 2 is a block diagram illustrating an example system that includesan IMD, a programming device, an access point, a server and one or morecomputing devices interconnected, and able to communicate with eachother, through a network.

FIG. 3 is a conceptual diagram illustrating an example therapy systemthat may be used to provide therapy to patient.

FIG. 4 is a functional block diagram of an example configuration ofcomponents of the IMD of FIG. 3.

FIG. 5 is a flow diagram illustrating example operation of an IMD inaccordance with one aspect of this disclosure.

FIG. 6 is a flow diagram illustrating example operation of an IMD inaccordance with another aspect of this disclosure.

FIG. 7 is a flow diagram illustrating example operation of an IMDautomatically determining parameters of the exposure operating mode inaccordance with one aspect of this disclosure.

FIG. 8 is a flow diagram illustrating example operation of an IMDrecommending parameters for the exposure operating mode to a user.

DETAILED DESCRIPTION

FIG. 1 is a conceptual diagram illustrating an environment 10 in whichan implantable medical device (IMD) 14 is exposed to a disruptive energyfield 11. IMD 14 is implanted within patient 12 to provide therapy to orto monitor a physiological condition of patient 12. The techniques,however, are not limited to devices implanted within patient 12. Forexample, the techniques may be used in conjunction with an externalmedical device that is adversely affected by disruptive energy field 11.

IMD 14 may be any of a variety of devices that provide therapy topatient 12, monitor a condition of patient 12, or both. For example, IMD14 may be a device that provides electrical stimulation therapy via oneor more implantable leads that include one or more electrodes (not shownin FIG. 1). In some instances, IMD 14 may be a device that provideselectrical stimulation therapy in the form of cardiac rhythm managementtherapy to a heart of patient 12 via leads implanted within one or moreatria and/or ventricles of the heart. The cardiac rhythm managementtherapy delivered by IMD 14 may include pacing, cardioversion,defibrillation and/or cardiac resynchronization therapy (CRT). In otherinstances, IMD 14 may be a device that provides electrical stimulationto a tissue site of patient 12 proximate a muscle, organ or nerve, suchas a tissue proximate a vagus nerve, spinal cord, brain, stomach, pelvicfloor or the like.

In addition to providing electrical stimulation therapy, IMD 14 maysense one or more physiological parameters of patient 12. When one ormore leads are implanted within the heart of patient 12, for example,electrodes of the leads may sense electrical signals attendant to thedepolarization and repolarizatoin of the heart to monitor a rhythm ofthe heart or detect particular heart conditions, e.g., tachycardia,bradycardia, fibrillation or the like. IMD 14 may sense a variety ofother physiologic parameters or other parameters related to a conditionof patient 12, including, for example, neurologic parameters,intracardiac or intravascular pressure, activity, posture, pH of bloodor other bodily fluids or the like. In some instances, IMD 14 may beused solely for monitoring a condition of patient 12. In other words,IMD 14 may not provide therapy to patient 12, but simply sense aphysiological or biological condition of patient 12.

In yet other instances, IMD 14 may be a device that delivers a drug ortherapeutic agent to patient 12 via a catheter. IMD 14 may deliver,e.g., using a pump, the drug or therapeutic agent to a specific locationof patient 12. IMD 14 may deliver the drug or therapeutic agent at aconstant or variable flow rate. Drug pumps, infusion pump or drugdelivery devices may be used to treat symptoms of a number of differentconditions. For example, IMD 14 may deliver morphine or ziconotide toreduce or eliminate pain, baclofen to reduce or eliminate spasticity,chemotherapy to treat cancer, or any other drug or therapeutic agent(including saline, vitamins, etc.) to treat any other condition and/orsymptom of a condition.

Environment 10 includes an energy source that generates disruptiveenergy field 11 to which IMD 14 is exposed. In the example illustratedin FIG. 1, the energy source is an MRI scanner 16. Although thetechniques of this disclosure are described with respect to disruptiveenergy field 11 generated by MRI scanner 16, the techniques may be usedto control operation of IMD 14 within environments in which other typesof disruptive energy fields are present. For example, IMD 14 may operatein accordance with the techniques of this disclosure in environments inwhich disruptive energy field 11 is generated by a CT scanner, X-raymachine, electrocautery device, diathermy device, ablation device,radiation therapy device, electrical therapy device, magnetic therapydevice, RFID security gate, or any other environment with devices thatradiate energy to produce magnetic, electromagnetic, electric fields orother disruptive energy fields.

MRI scanner 16 uses magnetic and radio frequency (RF) fields to produceimages of body structures for diagnosing injuries, diseases and/ordisorders. In particular, MRI scanner 16 generates a static magneticfield, gradient magnetic fields and/or RF fields. The static magneticfield is a non-varying magnetic field that is typically always presentaround MRI scanner 16 whether or not an MRI scan is in progress.Gradient magnetic fields are pulsed magnetic fields that are typicallyonly present while the MRI scan is in progress. RF fields are pulsed RFfields that are also typically only present while the MRI scan is inprogress.

Some or all of the various types of fields produced by MRI scanner 16may interfere with operation of IMD 14. In other words, one or more ofthe various types of fields produced by MRI scanner 16 may make updisruptive energy field 11. For example, the gradient magnetic and RFfields produced by MRI scanner 16 may induce energy on one or more ofthe implantable leads coupled to IMD 14. In some instances, IMD 14inappropriately detects the induced energy on the leads as physiologicalsignals, which may in turn cause IMD 14 to deliver undesired therapy orwithhold desired therapy. In other instances, the induced energy on theleads result in IMD 14 not detecting physiological signals that areactually present, which may again result in IMD 14 delivering undesiredtherapy or withholding desired therapy. The induced energy on the leadsmay be delivered to the tissue of patient 12 resulting in stimulation orheating of the tissue and/or nerve site adjacent to electrodes of theleads. Such heating may cause thermal damage to the tissue adjacent theelectrodes, possibly compromising pacing and sensing thresholds at thesite. In yet other instances, the induced energy may cause damage to oneor more components of IMD 14.

To reduce the undesirable effects of disruptive energy field 11, IMD 14is capable of operating in a mode that is less susceptible toundesirable operation during exposure to disruptive energy field 11,referred to herein as the “exposure mode” or “exposure operating mode.”Prior to being exposed or upon being exposed to disruptive energy field11, IMD 14 is configured from a normal operating mode (e.g., the currentoperating mode) to the exposure operating mode. IMD 14 may be configuredfrom the normal mode to the exposure mode automatically, e.g., inresponse to detection of disruptive energy field 11, or manually, e.g.,via an external programming device.

In the normal operating mode, IMD 14 operates in accordance with alldesired functionality using settings programmed by a physician,clinician or other user. When operating in the normal operating mode,IMD 14 may perform functions in a manner that does not specificallyaccount for the presence of strong disruptive energy fields. The normalmode may correspond with the operating mode that a physician or otheruser feels provides a most efficacious therapy for patient 12. Whileoperating in accordance with the normal operating mode, IMD 14 may sensephysiological events, deliver a number of different therapies, and logcollected data.

In the exposure mode, however, IMD 14 may perform functions in a mannerthat specifically accounts for the presence of strong disruptive energyfields. While operating in the exposure mode, IMD 14 may be configuredto operate with different functionality than when operating in thenormal operating mode. IMD 14 may, in some instances, be configured tooperate with reduced functionality. In other words, when configured tooperate in the exposure mode, IMD 14 may have only a subset of thefunctionality of the normal operating mode. For example, IMD 14 may notprovide sensing, not deliver therapy, delivery only a subset of possibletherapies, not log collected data or the like. In other instances, IMD14 may be operating with approximately the same functionality or evenincreased functionality in the exposure mode. For example, IMD 14 mayuse a different sensor or algorithm to detect cardiac activity of theheart of patient 12, such as pressure sensor measurements rather thanelectrical activity of the heart. In either case, it is desirable thatIMD 14 be reconfigured from the exposure operating mode to the normaloperating mode as soon as safely possible after exiting from environment10.

In accordance with one aspect of this disclosure, IMD 14 automaticallydetermines at least a portion of the parameters and, in some instancesall of the parameters, of the exposure operating mode based on storedinformation regarding sensed physiological events or therapy providedover a predetermined period of time. For example, IMD 14 may analyzeparameters of therapy, if any, provided over the predetermined period oftime, such as pacing modes in which the device operated over thepredetermined period of time, percentage of time during which therapy isprovided, amplitudes of the therapy energy delivered during thepredetermined period of time, pulse widths of the therapy energydelivered during the predetermined period of time, heart rate during thepredetermined period of time, or the like. Based on this analysis, thedevice may determine one or more parameters of the exposure operatingmode, such as a pacing mode and amplitude, pulse width, and/or rate ofthe therapy energy delivered during the exposure operating mode. IMD 14may automatically determine the parameters periodically ornon-periodically, e.g., in response to some input.

IMD 14 stores the automatically determined parameters of the exposureoperating mode and uses at least a portion of the parameters when it isconfigured into the exposure operating mode. In one instance, IMD 14 mayconfigure itself to operate in accordance with the automaticallydetermined parameters in response to detecting disruptive energy field11, which may in one example be the static magnetic field of MRI scanner16, the gradient magnetic fields of MRI scanner 16, or the RF fields ofMRI scanner 16. In this case, IMD 14 may be a fully automated MRConditional or MR Safe device that does not require any manualprogramming of the exposure operating mode parameters. This may reducethe service burden on the patient, physician, technician, clinician orother user involved in the process.

In another example, IMD 14 may receive, e.g., via telemetry, parametersfor the exposure operating mode from a physician, clinician, or otherperson. The IMD may continue to automatically determine parameters ofthe exposure operating mode and compare the automatically determinedparameters with the parameters that were manually programmed. If thereare differences between the automatically determined parameters and themanually programmed parameters, IMD 14 may initiate an alert to patient12 and/or a physician notifying them that the automatically determinedparameters differ from the manually programmed parameters. In someinstances, IMD 14 may only notify patient 12 and/or the physician if thedifferences are determined to be significant. Whether a difference isdetermined to be significant may be determined differently depending onthe circumstances of a particular patient 12, the physician treating thepatient or the like. Alternatively or additionally, IMD 14 may providethe automatically determined parameters to the physician or clinician atthe time of the manual programming. In other words, IMD 14 may suggestappropriate parameters for the exposure operating mode. The physician,clinician or other user may accept the suggested parameters or adjustone or more of the suggested parameters. In the instances in whichmanually programming is involved, IMD 14 may enter and exit the exposureoperating mode at the time of manual programming or automatically upondetecting disruptive energy field 11 as will be described in furtherdetail.

By automatically determining the parameters of the exposure operatingmode, IMD 14 may automatically configure itself to be MR Conditional orMR Safe without requiring manual programming by a physician, clinicianor other person. Moreover, IMD 14 continues to update the parameters ofthe exposure operating mode until just before exposure to disruptiveenergy field 11. As such, automatically determining the parameters ofthe exposure operating mode may provide an added safety mechanism incase the condition of the patient changes from the time between themanual programming of the parameters of the exposure operating mode andthe MRI scan.

Although described with respect to a medical environment that generatesdisruptive energy fields, the techniques of this disclosure may be usedto operate IMD 14 within non-medical environments that includedisruptive energy fields. Additionally, the techniques of thisdisclosure may also be used to operate IMD 14 within environments thatproduce disruptive energy fields that are intermittent in nature.

FIG. 2 is a block diagram illustrating an example system that includesIMD 14, a programming device 18, an access point 20, a network 22, aserver 24 and one or more computing devices 26A-26N. In the example ofFIG. 2, programming device 18, access point 20, server 24 and computingdevices 26 are interconnected, and able to communicate with each other,through network 22. Programming device 18, access point 20, server 24,and computing devices 26A-26N may each include one or more processors,such as one or more microprocessors, digital signal processors (DSPs),application specific integrated circuits (ASICs), field-programmablegate arrays (FPGAs), programmable logic circuitry, or the like, that mayperform various functions and operations, such as those describedherein.

Programming device 18 may be a dedicated hardware device with dedicatedsoftware for programming of IMD 14. Alternatively, programming device 18may be an off-the-shelf computing device running an application thatenables programming device 18 to program IMD 14. In some examples,programming device 18 may be a handheld computing device or a computerworkstation. Programming device 18 may, in some instances, include aprogramming head that may be placed proximate to the patient's body nearthe implant site of IMD 14 in order to improve the quality or securityof communication between IMD 14 and programming device 18. Programmingdevice 18 may include a user interface that receives input from the userand/or displays data to the user.

Programming device 18 may communicate with IMD 14 via wirelesscommunication using any techniques known in the art. Examples ofcommunication techniques may include, for example, magnetic telemetry,low frequency telemetry or radio frequency (RF) telemetry, but othertechniques are also contemplated. In some instances, programming device18 and IMD 14 may communicate in the 402-405 MHz frequency band inaccordance with the Medical Implant Communications Service (MICS)frequency band regulation, in the 401-402 MHz or 405-406 MHz frequencybands in accordance with the Medical External Data Service (MEDS) bandregulations, in the unlicensed industrial, scientific and medical (ISM)band, or other frequency band.

A user, such as a physician, technician, clinician or patient, mayinteract with a programming device 18 to communicate with IMD 14. Forexample, the user may interact with programming device 18 to retrievephysiological or diagnostic information or history of therapiesdelivered from IMD 14. In the case of a cardiac implantable medicaldevice, for instance, the user may use programming device 18 to retrieveinformation from IMD 14 regarding the rhythm of the heart of patient 12,trends therein over time, or cardiac arrhythmia episodes. As anotherexample, the user may use programming device 18 to retrieve informationfrom IMD 14 regarding other sensed physiological parameters of patient12, such as electrical depolarization/repolarization signals from theheart (referred to as an “electrogram” or EGM), intracardiac orintravascular pressure, activity, posture, respiration or thoracicimpedance. As another example, the user may use programming device 18 toretrieve information from IMD 14 regarding the performance or integrityof IMD 14 or other components of therapy system 30, such as leads or apower source of IMD 14.

The user may also interact with programming device 18 to program IMD 14,e.g., select values for operational parameters of IMD 14. For electricalstimulation therapies, for example, the user may interact withprogramming device 18 to program a therapy progression, select anelectrode or combination of electrodes of leads 34 and 36 to use fordelivering electrical stimulation (pulses or shocks), select parametersfor the electrical pulse or shock (e.g., pulse amplitude, pulse width,or pulse rate), select electrodes or sensors for use in detecting aphysiological parameter of patient 12, or the like. By programming theseparameters, the physician or other user can attempt to generate anefficacious therapy for patient 12 that is delivered via the selectedelectrodes.

In some instances, a user interacts with programming device 18 toprogram IMD 14 into the exposure mode prior to patient 12 undergoing amedical procedure in which IMD 14 will be exposed to a disruptive energyfield 11, e.g., before undergoing an MRI scan. In accordance with oneaspect of this disclosure, IMD 14 may transmit automatically generatedparameters suggested for the exposure operating mode to programmingdevice 18 for presentation to the user. The user may view the suggestedparameters automatically determined by IMD 14 and either accept thesuggested parameters or change one or more of the suggested parameters.The device may then be programmed into the exposure mode using theparameters at that time or at a later time (e.g., in response todetecting the disruptive energy field 11).

The user may also reprogram IMD 14 from the exposure mode to a normalmode after the MRI scan is finished. Often times, an individualperforming the MRI scan is not familiar with programming implanteddevices. As such, a technician familiar with programming implanteddevices needs to be present before and after the medical procedure, theMRI scan in this case. This is often burdensome as the medical proceduremay take several hours. As such, IMD 14 may, in other instances,automatically reconfigure itself from the exposure operating mode to thenormal operating mode. In other words, IMD 14 may revert to the normaloperating mode without the technician using programming device 18 tomanually reprogram IMD 14.

IMD 14 may communicate with programming device 18 via a first wirelessconnection and communicate with access point 20 via a second wirelessconnection. Programming device 18 and/or access point 20 may connect tonetwork 22 via any of a variety of wired or wireless connections, suchas telephone dial-up, digital subscriber line (DSL), cable modemconnection, Infrared Data Association (IrDA), Bluetooth, IEEE 802.11,General Packet Radio Service (GPRS) or the like. As such, programmingdevice 18 and access point 20 may forward data from IMD 14 to any otherdevice connected to network 22.

In some embodiments, access point 20 may be co-located with patient 14and may comprise one or more programming units and/or computing devices(e.g., one or more monitoring units) that may perform various functionsand operations described herein. For example, access point 20 mayinclude a home-monitoring unit that is co-located with patient 14 andthat may monitor the activity of IMD 14. In some embodiments, server 24or computing devices 26 may control or perform any of the variousfunctions or operations described herein, e.g., view or change theautomatically determined parameters of the exposure operating mode ofIMD 14. In one aspect of this disclosure, IMD 14 may initially bemanually programmed with parameters for the exposure operating mode. IMD14 may, however, continue to automatically determine parameters for theexposure operating mode, e.g., on a periodic basis, after the manualprogramming. IMD 14 may compare the automatically generated parameterswith the manually programmed parameters and, if there are anydifferences, IMD 14 may generate an alert for the physician indicatingthe difference. For example, IMD 14 may send an alert to server 24 orone or more of computing devices 26A-26N via access point 20 and network22. Alternatively, the patient may be notified that he/she may need torevisit the physician prior to the MRI scan to have the exposureoperating mode updated. IMD 14 may, in addition to or instead of thealert, override the manually programmed parameters with theautomatically generated parameters either automatically or in responseto a signal from a physician sent remotely via network 22. IMD 14 may,in some instances, only send the alert if the difference(s) isdetermined to be significant. Whether a difference is determined to besignificant may be determined differently depending on the circumstancesof a particular patient 12, the physician treating the patient or thelike.

In some cases, server 24 may be configured to provide a secure storagesite for archival of sensing integrity information that has beencollected from IMD 14 and/or programming device 18. In some cases,programming device 18 or server 24 may assemble information, such as theautomatically determined parameters of the exposure operating mode, inweb pages or other documents for viewing by trained professionals, suchas clinicians, via viewing terminals associated with computing devices26. The system of FIG. 2 may be implemented, in some aspects, withgeneral network technology and functionality similar to that provided bythe Medtronic CareLink® Network developed by Medtronic, Inc., ofMinneapolis, Minn.

FIG. 3 is a conceptual diagram illustrating an example therapy system 30that may be used to provide therapy to patient 12. Therapy system 30includes an IMD 32 and leads 34 and 36 that extend from IMD 32. IMD 32may, for example, correspond to IMD 14 of FIG. 1 and FIG. 2.

In the example illustrated in FIG. 3, IMD 32 is an implantable cardiacdevice that senses electrical activity of a heart 38 of patient 12and/or provides electrical stimulation therapy to heart 38 of patient12. The electrical stimulation therapy to heart 38, sometimes referredto as cardiac rhythm management therapy, may include pacing,cardioversion, defibrillation and/or cardiac resynchronization therapy(CRT). The combinations of cardiac therapies provided may be dependenton a condition of patient 12. In some instances, IMD 32 may provide notherapy to patient 12, but instead provide only sensing of electricalactivity or other variable of heart 30, such as in the case of animplantable loop recorder.

In the illustrated example, lead 34 is a right ventricular (RV) leadthat extends through one or more veins (not shown), the superior venacava (not shown), and right atrium 40, and into right ventricle 42 ofheart 38. Lead 34 includes electrodes 44 and 46 located along a distalend of lead 34. In the illustrated example, lead 36 is right atrial (RA)lead that extends through one or more veins and the superior vena cava,and into the right atrium 40 of heart 38. Lead 36 includes electrodes 50and 52 located along a distal end of lead 36.

Electrodes 44 and 50 may take the form of extendable helix tipelectrodes mounted retractably within an insulative electrode head (notshown) of respective leads 34 and 36. Electrodes 46 and 52 may take theform of ring electrodes. In other embodiments, electrodes 44, 46, 50 and52 may be other types of electrodes. For example, electrodes 44, 46, 50and 52 may all be ring electrodes located along the distal end of theassociated lead 34 or 36. Additionally, either or both of leads 34 and36 may include more than two electrodes or only a single electrode.

Each of the electrodes 44, 46, 50 and 52 may be electrically coupled toa respective conductor within the body of its associated lead 34 and 36.The respective conductors may extend from the distal end of the lead tothe proximal end of the lead and couple to circuitry of IMD 32. Forexample, leads 34 and 36 may be electrically coupled to a stimulationmodule, a sensing module, or other modules of IMD 32 via connector block54. In some examples, proximal ends of leads 34 and 36 may includeelectrical contacts that electrically couple to respective electricalcontacts within connector block 54. In addition, in some examples, leads34 and 36 may be mechanically coupled to connector block 54 with the aidof set screws, connection pins or another suitable mechanical couplingmechanism.

When IMD 32 is capable of delivering electrical stimulation therapy, IMD32 delivers the therapy (e.g., pacing pulses) to heart 38 via anycombination of electrodes 44, 46, 50 and 52 to cause depolarization ofcardiac tissue of heart 14. For example, IMD 32 may deliver bipolarpacing pulses to right atrium 40 via electrodes 50 and 52 of lead 36and/or may deliver bipolar pacing pulses to right ventricle 42 viaelectrodes 44 and 46 of lead 34. In another example, IMD 32 may deliverunipolar pacing pulses to atrium 40 and ventricle 42 using a housingelectrode (not shown) in conjunction with one of electrodes 44, 46, 50and 52. The housing electrode may be formed integrally with an outersurface of the hermetically-sealed housing of IMD 32 or otherwisecoupled to the housing. In some examples, the housing electrode isdefined by an uninsulated portion of an outward facing portion of thehousing of IMD 32.

Electrodes 44, 46, 50 and 52 may also sense electrical signals attendantto the depolarization and repolarization of heart 30. The electricalsignals are conducted to IMD 32 via one or more conductors of respectiveleads 34 and 36. IMD 32 may use any combinations of the electrodes 44,46, 50, 52 or the housing electrode for unipolar or bipolar sensing. Assuch, the configurations of electrodes used by IMD 32 for sensing andpacing may be unipolar or bipolar depending on the application. IMD 32may analyze the sensed signals to monitor a rhythm of heart 38 or detectan arrhythmia of heart 38, e.g., tachycardia, bradycardia, fibrillationor the like. In some instances, IMD 32 provides pacing pulses (or othertherapy) to heart 38 based on the cardiac signals sensed within heart38. In other words, pacing may be responsive to the sensed events.

As described above, exposure of an implantable medical device, such asIMD 32 to a disruptive energy field 11 (FIG. 1) may result inundesirable operation. For example, gradient magnetic and RF fieldsproduced by MRI scanner 16 (FIG. 1) may induce energy on one or more ofelectrodes 44, 46, 50 and 52 of respective ones of implantable leads 34and 36 or on the housing electrode. In some instances, IMD 32inappropriately detects the induced energy on electrodes 44, 46, 50 and52 as physiological signals, which may in turn cause IMD 32 to deliverundesired therapy or withhold desired therapy. In other instances, theinduced energy on electrodes 44, 46, 50 and 52 result in IMD 32 notdetecting physiological signals that are actually present, which mayagain result in IMD 32 delivering undesired therapy or withholdingdesired therapy. In further instances, the induced energy on electrodes44, 46, 50 and 52 result in stimulation or heating of the tissue and/ornerve site adjacent to electrodes 44, 46, 50 and 52 or the housing ofIMD 32. Such heating may result in thermal damage to the tissue adjacentthe electrodes, possibly compromising pacing and sensing thresholds atthe site. Yet another possible adverse affect of disruptive energy field11 is damage to circuitry within IMD 32.

Configuring IMD 32 into an exposure operating mode may reduce, andpossibly eliminate, the undesirable operation of IMD 32. As such, IMD 32may be configured to operate in the exposure operating mode prior to orimmediately subsequent to entering the environment in which thedisruptive energy field 11 is present. In accordance with one aspect ofthis disclosure, IMD 32 automatically determines at least a portion ofthe parameters and, in some instances all of the parameters, of theexposure operating mode based on stored information regarding sensedphysiological events or provided therapy prior to entering theenvironment with disruptive energy field 11. At least a portion of theseautomatically determined parameters are used in configuring IMD 32 intothe exposure operating mode as described in further detail in thisdisclosure. IMD 32 may, for example, automatically configure itself intothe exposure operating mode using the automatically determinedparameters. In another example, the automatically determined parametersmay be provided to a user (e.g., physician) as a suggested set ofparameters for the exposure operating mode and the user accepts theparameters as is or modifies one or more of the parameters to manuallyconfigure IMD 32 into the exposure operating mode. In a further example,IMD 32 may update or override manually programmed parameters withparameters that are automatically determined subsequent to the manualprogramming.

The configuration of therapy system 30 illustrated in FIG. 3 is merelyan example. In other examples, therapy system 30 may include more orfewer leads extending from IMD 32. For example, IMD 32 may be coupled tothree leads, e.g., a third lead implanted within a left ventricle ofheart 30. In another example, IMD 32 may be coupled to a single leadthat is implanted within either an atrium or ventricle of heart 38. Assuch, IMD 32 may be used for single chamber or multi-chamber cardiacrhythm management therapy.

In addition to more or fewer leads, each of the leads may include moreor fewer electrodes. In instances in which IMD 32 is used for therapyother than pacing, e.g., defibrillation or cardioversion, the leads mayinclude elongated electrodes, which may, in some instances, take theform of a coil. IMD 32 may deliver defibrillation or cardioversionshocks to heart 38 via any combination of the elongated electrodes andhousing electrode. As another example, therapy system 30 may includeleads with a plurality of ring electrodes, e.g., as used in someimplantable neurostimulators.

In still other examples, a therapy system may include epicardial leadsand/or patch electrodes instead of or in addition to the transvenousleads 34 and 36 illustrated in FIG. 3. Further, IMD 32 need not beimplanted within patient 12. In examples in which IMD 32 is notimplanted in patient 12, IMD 32 may deliver electrical stimulationtherapy to heart 38 via percutaneous leads that extend through the skinof patient 12 to a variety of positions within or outside of heart 38.

The techniques of this disclosure are described in the context ofcardiac rhythm management therapy for purposes of illustration. Thetechniques of this disclosure, however, may be used to operate an IMDthat provides other types of electrical stimulation therapy. Forexample, the IMD may be a device that provides electrical stimulation toa tissue site of patient 12 proximate a muscle, organ or nerve, such asa tissue proximate a vagus nerve, spinal cord, brain, stomach, pelvicfloor or the like. Moreover, the techniques may be used to operate anIMD that provides other types of therapy, such as drug delivery orinfusion therapies. As such, description of these techniques in thecontext of cardiac rhythm management therapy should not be limiting ofthe techniques as broadly described in this disclosure.

FIG. 4 is a functional block diagram of an example configuration ofcomponents of IMD 32. In the example illustrated by FIG. 4, IMD 32includes a control processor 60, sensing module 62, stimulation module66, disruptive field detector 68, telemetry module 70, memory 72, powersource 74 and alarm module 76. Memory 72 may include computer-readableinstructions that, when executed by control processor 60 or othercomponent of IMD 32, cause one or more components of IMD 32 to performvarious functions attributed to those components in this disclosure.Memory 72 may include any volatile, non-volatile, magnetic, optical, orelectrical media, such as a random access memory (RAM), read-only memory(ROM), non-volatile RAM (NVRAM), static non-volatile RAM (SRAM),electrically-erasable programmable ROM (EEPROM), flash memory, or anyother storage media.

The various components of IMD 32 are coupled to power source 74, whichmay include a rechargeable or non-rechargeable battery. Anon-rechargeable battery may be capable of holding a charge for severalyears, while a rechargeable battery may be inductively charged from anexternal device, e.g., on a daily or weekly basis. Power source 74 alsomay include power supply circuitry for providing regulated voltagesand/or current levels to power the various components of IMD 32.

Control processor 60 may include any one or more of a microprocessor, acontroller, a digital signal processor (DSP), an application specificintegrated circuit (ASIC), a field-programmable gate array (FPGA), orequivalent discrete or integrated circuitry, including analog circuitry,digital circuitry, or logic circuitry. The functions attributed tocontrol processor 60 herein may be embodied as software, firmware,hardware or any combination thereof.

Under the control of processor 60, telemetry module 70 may receivedownlink telemetry from and send uplink telemetry to programming device18 or access point 20 with the aid of an antenna, which may be internaland/or external to IMD 32. Telemetry module 70 includes any suitablehardware, firmware, software or any combination thereof forcommunicating with another device, such as programming device 18. Forexample, telemetry module 70 may include appropriate modulation,demodulation, encoding, decoding, frequency conversion, filtering, andamplifier components for transmission and reception of data.

Control processor 60 controls stimulation module 66 to deliverelectrical stimulation therapy to heart 38 via one or more of electrodes44, 46, 50, 52 and/or the housing electrode (FIG. 3). Stimulation module66 is electrically coupled to electrodes 44, 46, 50 and 52, e.g., viaconductors of the respective lead 34 and 36, or, in the case of thehousing electrode, via an electrical conductor disposed within thehousing of IMD 32. Control processor 60 controls stimulation module 66to deliver electrical pacing pulses with the amplitudes, pulse widths,rates, electrode combinations or electrode polarities specified by aselected therapy program. For example, electrical stimulation module 66may deliver bipolar pacing pulses via ring electrodes 46 and 52 andrespective corresponding helical tip electrodes 44 and 50 of leads 34and 36, respectively. Stimulation module 66 may deliver one or more ofthese types of stimulation in the form of other signals besides pulsesor shocks, such as sine waves, square waves, or other substantiallycontinuous signals. In addition to pacing pulses, stimulation module 66may, in some instances, deliver other types of electrical therapy, suchas defibrillation therapy or cardioversion therapy.

Stimulation module 66 may include a switch module (not shown) andcontrol processor 60 may use the switch module to select, e.g., via adata/address bus, which of the available electrodes are used to deliverpacing, resynchronization, cardioversion, or defibrillation therapy. Theswitch module may include a switch array, switch matrix, multiplexer, orany other type of switching device suitable to selectively couplestimulation energy to selected electrodes.

Sensing module 62 is configured to receive signals from one or moresensors. In one example, sensing module 62 is configured to receivesignals sensed by one or more of electrodes 44, 46, 50, 52 and thehousing electrode. In this manner, electrodes 44, 46, 50, 52, and thehousing electrode may operate as sense electrodes in addition to orinstead of being used for delivering electrical stimulation therapy. Inother instances, leads 34 and 36 may include one or more electrodesdedicated for sensing. In further examples, sensing module 62 is coupledto one or more sensors that are not included on leads 34 and 36, e.g.,via a wired or wireless coupling. Such sensors may include, but are notlimited to, pressure sensors, accelerometers, flow sensors, bloodchemistry sensors, activity sensors or other type of physiologicalsensor. Signals monitored by sensing module 62 may be stored in memory72.

Sensing module 62 may receive signals sensed by any number of sensingconfiguration defined by various combinations of one or more ofelectrodes 44, 46, 50 and 52. Control processor 60 may select theelectrodes that function as sense electrodes, sometimes referred to as asensing configuration or sensing vector, in order to monitor electricalactivity of heart 30. In one example, sensing module 62 may include aswitch module (not shown) to select which of the available electrodesare used to sense the heart activity. Control processor 60 may selectthe electrodes that function as sense electrodes, or the sensingelectrode configuration, via the switch module within sensing module 62,e.g., by providing signals via a data/address bus.

Sensing module 62 may store the sensed signals in memory 72. In someinstances, sensing module 62 may store the sensed signals in raw form.In other instances, sensing module 62 may process the sensed signals andstore the processed signals in memory 72. Sensing module 62 may, forexample, include multiple detection channels configured to detectdifferent cardiac events, such as intrinsic or paced atrial events,intrinsic or paced ventricular events, repolarization of the ventricles,and the like. Each of the detection channels may comprise an amplifier,filter or other components. Sensing module 62 may amplify and filter thesensed signal and store the filtered signal in memory 72. The signalsstored by sensing module 62 may, in some cases, be retrieved and furtherprocessed by control unit 60.

As described above, processor 60 may be configurable to operate IMD 32in a number of different operating modes, such as the normal operatingmode and the exposure operating mode. Although the techniques of thisdisclosure are described with respect to two operating modes, i.e., thenormal and exposure mode, processor 60 may operate IMD 32 in accordancewith and switch between more than two operating modes. In the normaloperating mode, processor 60 operates IMD 32 in accordance with settingsprogrammed by a physician, clinician or other user. The normal operatingmode may correspond with the operating mode that a physician or otheruser feels provides a most efficacious therapy for patient 12. Thenormal operating mode may vary from patient to patient depending on thecondition of patient 12 for which IMD 32 is providing therapy.

The normal operating mode of IMD 32 may be one or more of any of anumber of pacing modes, including DDD, VVI, DVI, VDD, AAI, DDI, DDDR,VVIR, DVIR, VDDR, AAIR, DDIR, VOO, AOO, DOO, ODO and other modes ofsingle and dual-chamber pacing or sensing. For example, the normaloperating mode may be an atrial based pacing mode, such as AAI or ADIpacing mode, if IMD 32 is providing therapy to a patient experiencingbradycardia. As another example, the normal operating mode may be adual-chamber pacing mode, such as a DDD pacing mode, if IMD 32 isproviding therapy to a patient with unreliable A-V conduction.

In the aforementioned operating modes, the abbreviations of whichconform to the NBG Pacemaker Code, the first letter in the pacing modeindicates the chamber or chambers paced and may take on the letter “D”indicating dual-chamber (i.e., atrial and ventricle both paced), “V”indicating a ventricle is paced, “A” indicating an atrium is paced, or“O” indicating no chamber is paced. The second letter indicates thechamber or chambers sensed and may take on the letter “D” indicatingdual-chamber (i.e., atrial and ventricle both paced), “V” indicating aventricle is paced, “A” indicating an atrium is paced, or “O” indicatingno chamber is paced. The third letter indicates mode or modes ofresponse to sensing and may take on the letter “T” indicating triggeredpacing (i.e., pacing is provided in response to the sensing), “I”indicating inhibited pacing (i.e., pacing is stopped based in responseto the sensing), “D” indicating dual response (i.e., triggered andinhibited) and “O” for no response. The fourth letter indicatesprogrammable functions and may take on the letter “R” indicating ratemodulated pacing, as well as other letters not explained here. Althoughnot described here, a fifth letter may be provided in accordance withthe NBG Pacemaker Code indicating anti-tachycardia functions.

When IMD 32 is configured to generate and deliver pacing pulses to heart30, control processor 60 controls a pacer timing and control module (notshown), which may be embodied as hardware, firmware, software, or anycombination thereof. The pacer timing and control module may comprise adedicated hardware circuit, such as an ASIC, separate from othercomponents of control processor 60, such as a microprocessor, orcomprise a software module executed by a component of control processor60, which may be a microprocessor or ASIC.

The pacer timing and control module may include programmable counterswhich control the basic time intervals associated with various singleand dual-chamber pacing modes. Intervals defined by the pacer timing andcontrol module within control processor 60 may include, for example,atrial and ventricular pacing escape intervals and refractory periodsduring which sensed atrial and ventricular events are ineffective torestart timing of the escape intervals. As another example, the pacetiming and control module may define a blanking period, and providesignals to sensing module 62 to blank one or more channels, e.g.,amplifiers, for a period during and after delivery of electricalstimulation to heart 30. The durations of these intervals may bedetermined by control processor 60 in response to stored program data inmemory 72. The pacer timing and control module of control processor 60may also determine the amplitude and pulse width of the cardiac pacingpulses.

During pacing, escape interval counters within the pacer timing andcontrol module of control processor 60 may be reset upon sensing ofR-waves and P-waves with detection channels of sensing module 62.Additionally, the value of the count present in the escape intervalcounters when reset by sensed R-waves and P-waves may be used by controlprocessor 60 to measure the durations of R-R intervals, P-P intervals,P-R intervals and R-P intervals, which are measurements that may bestored in memory 72. Control processor 60 may analyze these variousintervals to determine conditions of heart 30, such as to detect atachyarrhythmia event. When IMD 32 is capable of providingdefibrillation therapy, the R-R intervals may be used to increment a VFcounter to control delivery of cardioversion or defibrillation shocks.For example, the VF counter may be incremented in response to detectionof short R-R intervals, and possibly in response to other events such asR-R interval variance. The VF counter triggers delivery of adefibrillation shock when the counter reaches a number of intervals fordetection (NID) threshold. Additionally, control processor 60 may beginan anti-tachyarrhythmia pacing regimen prior to delivery of thedefibrillation shock.

The normal operating mode may be susceptible to undesirable operationwhen IMD 32 is placed within environment 10 with disruptive energy field11. In some instances, sensing module 62 inappropriately detects theinduced energy on the leads as physiological signals (e.g., intrinsiccardiac events). In other words, IMD 32 senses a physiological signalwhen one is not actually present. At the very least, the detection ofthe induced energy caused by disruptive energy field 11 results in thestored data not accurately representing the actual function andcondition of heart 38. Moreover, the detection of the induced energycaused by disruptive energy field 11 may in turn cause undesirableoperation of IMD 32.

For example, when the current or normal operating mode is a pacing modewith inhibit response to sensing, processor 60 may not deliver (i.e.,withhold) a desired pacing pulse in response to sensing the inducedenergy from disruptive energy field 11 as a physiological signal. Forexample, processor 60 may identify the induced energy as a ventricularevent. This may result in control processor 60 resetting the ventricularescape interval counter, thereby inhibiting delivery of a desired pacingpulse. In other instances when the normal operating mode is a dualchamber pacing mode with inhibit and trigger response to sensing,processor 60 may also deliver an undesirable pacing pulse in addition towithholding a desired pacing pulse in response to sensing the inducedenergy from disruptive energy field 11 as a physiological signal. Inparticular, sensing the induced energy from the disruptive energy fieldas a physiological signal may inappropriately start an escape intervalafter which an undesired pacing pulse is delivered. This may result indangerously fast heart rhythms and may lead to tachyarrhythmia orfibrillation.

In other instances, the induced energy on the leads may result in IMD 32not sensing actual physiological signals that are present. Processor 60may, for example, initiate a blanking period in response to the inducedenergy on the leads. During the blanking period, sensing module 62 maypower down one or more sense amplifiers. As such, sensing module 62 willfail to detect any intrinsic physiological event that occurs during theblanking period. Failure to detect this actual physiological event mayagain result in IMD 32 delivering undesired therapy or withholdingdesired therapy.

In further instances, the induced energy on one or more of leads 34 and36 may result in inadvertent stimulation or heating of the tissue and/ornerve site adjacent to any of electrodes 44, 46, 50 and 52 of respectiveleads 34 and 36. Such heating may result in thermal damage to the tissueadjacent the electrodes. This may in turn possibly compromise pacing andsensing thresholds at the site.

To reduce the adverse effects of disruptive energy field 11, controlprocessor 60 may be configured to operate IMD 32 in the exposureoperating mode. The exposure operating mode is typically lesssusceptible to undesirable operation in disruptive energy field 11 thanthe normal operating mode. In other words, operating IMD 32 in theexposure mode may reduce if not eliminate some or all of the adverseeffects that disruptive energy field 11 have on therapy delivery topatient 12. When operating in the exposure operating mode, controlprocessor 60 is configured to operate with different functionalitycompared to the normal operating mode. Processor 60 may, in someinstances, be configured to operate with reduced functionality. Forexample, processor 60 may not provide sensing, not deliver therapy,delivery only a subset of possible therapies, not log collected data orthe like. In other instances, processor 60 may be operating withapproximately the same functionality or even increased functionality inthe exposure mode. For example, processor 60 may use a different sensoror algorithm to detect cardiac activity of the heart of patient 12, suchas pressure sensor measurements rather than electrical activity of theheart.

Processor 60 automatically determines at least a portion of theparameters and, in some instances all of the parameters, of the exposureoperating mode based on stored information regarding sensedphysiological events and/or therapy provided over a predetermined periodof time. To that end, processor 60 may include an exposure modeparameter determination module that analyzes the stored information togenerate the one or more parameters. In automatically determining theparameters of the exposure operating mode, processor 60 is particularlyinterested in stored information pertaining to physiological events andtherapy within a short period of time prior to the determination.Processor 60 may analyze the data regarding sensed physiological eventsand/or therapy provided within the last hour, two hours, four hours, orother predetermined period of time which may be configured by thephysician. To the contrary, processor 60 may analyze stored informationover a much longer period of time, e.g., a day, week or even longer,during normal device operation to identify trends, diagnose the efficacyof the therapy, or the like.

Processor 60 may periodically determine the parameters of the exposureoperating mode. For example, processor 60 may periodically determine theparameters of the exposure operating mode every hour, two hours, fourhours, daily, or the like. In some instances, processor 60 maycontinuously determine the parameters of the exposure operating mode onthe periodic basis. In other instances, IMD 32 may begin to periodicallydetermine the parameters of the exposure operating mode in response tosome event, e.g., in response to receiving a command from a programmer,a home monitoring system, a hand-held patient monitor or the like,either directly or remotely via network 22. For example, a physician maysend a command to IMD 32 to notify IMD 32 that an MRI scan will beperformed and, in response to the command, processor 60 mayautomatically determine the parameters of the exposure operating mode.As another example, processor 60 may begin to periodically determine theparameters of the exposure operating mode after a physician manuallyprograms an initial set of exposure operating mode parameters. In thismanner, IMD 32 may notify the physician and/or automatically change theexposure operating mode parameters if the automatically generatedparameters differ from the manually programmed parameters. In somecases, IMD 32 may require that the automatically generated parametersdiffer significantly from the manually programmed parameters beforenotifying the physician of the differences and/or automatically changingthe exposure operating mode parameters. As described in further detailbelow, whether a difference is determined to be significant may bedetermined differently depending on the circumstances of a particularpatient 12, the physician treating the patient or the like.

As a further example, processor 60 may automatically determine theparameters of the exposure operating mode in response to detectingexposure to environment 10. Processor 60 may, for instance,automatically determine the parameters of the exposure operating mode inresponse to detecting a static magnetic field having an amplitudecorresponding with MRI scanner 16, and configure IMD 32 to operate inaccordance with the parameters prior to exposure to the gradient or RFfields of MRI scanner 16. In this case, disruptive energy field detector68 may be a Hall sensor or other magnetic field sensor.

In automatically determining the parameters of the exposure operatingmode, processor 60 may analyze any of a variety of information stored inmemory 72 related to sensed physiological events and/or therapyprovided. For example, processor 60 may determine whether any therapywas provided over the predetermined period of time and, if any therapywas provided, the parameters of the therapy provided. The parameters ofthe therapy provided that may be analyzed by processor 60 includeoperating modes in which the device operated, percentage of time duringwhich therapy is provided, amplitudes of the therapy energy delivered,pulse widths of the therapy energy delivered, PAV intervals (i.e., theamount of time that elapsed between a paced atrial event a pacedventricular event), pacing capture thresholds (e.g., rheobase andchronaxie), sensing amplitudes, arrhythmias or the like. Additionally,processor 60 may analyze sensed information or information determinedbased on sensed information to automatically determine the parameters ofthe exposure operating mode. For example, IMD 32 may analyze the heartrate of patient 12 during the predetermined period of time.

Based on the analysis of the stored information, processor 60 determinesone or more parameters of the exposure operating mode. Processor 60 maydetermine an operating mode to use when programmed into the exposureoperating mode based on a pacing percentage and/or a previous pacingmode. For example, processor 60 may determine a pacing percentage forthe predetermined period of time (e.g., 1-4 hours). The pacingpercentage may be computed by dividing the number of cardiac cyclesduring which a pacing pulse was delivered during the predeterminedperiod of time by the total number of cardiac cycles during thepredetermined period of time. If the pacing percentage is less than athreshold pacing percentage (e.g., 5%), processor 60 selects asense-only operating mode as the exposure operating mode, e.g., ODO,OAO, or OVO. Because there is no pacing in these operating modes, suchoperating modes may prevent processor 60 from delivering undesirablestimulation or withholding desirable stimulation.

If the pacing percentage is greater than or equal to the thresholdpacing percentage, processor 60 selects an operating mode in whichpacing therapy is provided. In other words, if the pacing percentage isgreater than or equal to the threshold pacing percentage, processor 60may operate as if patient 12 is pacing dependent and select an operatingmode in which asynchronous pacing is provided. The asynchronous pacingmode may have no sensing functionality, e.g., AOO, VOO or DOO pacingmode, or include sensing functionality but have no mode of response tothe sensing, e.g., AAO, AVO, ADO, VVO, VAO, VDO, DDO, DAO or DVO pacingmode. In either of these cases, the pacing provided is not responsive tothe sensing, e.g., no trigger or inhibit functionality. As such, theinduced energy on the leads caused by disruptive energy field 11 doesnot result in undesirable operation of IMD 32. The threshold pacingpercentage may be programmed by a physician and may take on a higher orlower value. In one instance the threshold percentage may be 0% suchthat if any pacing is delivered within the predetermined period of time,an operating mode in which pacing therapy is delivered is selected.

When processor 60 determines that the exposure operating mode should bea pacing mode, e.g., the pacing percentage is greater than or equal tothe threshold pacing percentage, processor 60 may analyze the previousoperating modes to determine which of the pacing modes to select.Processor 60 may, for example, select the dual-chamber pacing mode(e.g., DOO) if IMD 32 has been operated in any dual-chamber mode duringthe predetermined time period. If IMD 32 has not been operated in anydual-chamber mode during the predetermined time period, processor 60selects either a ventricular-based pacing mode (e.g., VOO) or an atrialbased pacing mode (e.g., AOO) based on the previously configured mode.As described above, however, processor 60 may select a pacing mode thatincludes sensing functionality but the pacing is not responsive to thesensing, e.g., no trigger or inhibit functionality.

Additionally, processor 60 may determine one or more parameters of thepacing modes based on the stored information, such as a pacing rate, apacing amplitude, a pacing width, a PAV interval or the like. Processor60 may analyze an average heart rate during the predetermined period oftime and select a pacing rate for the pacing pulses delivered exposureoperating mode based on the analysis. For example, processor 60 may seta pacing rate of 85 beats per minute (bpm) for the selected pacing modewhen the average heart rate during the predetermined period of time isless than or equal to a threshold heart rate (e.g., 65 bpm) and set thepacing rate to 25 percent higher than the average heart rate when theaverage heart rate during the predetermined period of time is greaterthan the threshold heart rate.

Alternatively, or additionally, processor 60 may analyze pacingamplitudes during the predetermined period of time and select a pacingamplitude for the pacing pulses delivered during the exposure operatingmode based on the analysis. For example, processor 60 may set the pacingamplitude for pacing pulses delivered during the exposure operating modeat a predetermined voltage (e.g., 5 Volts (V)) when the highest pacingamplitude of the predetermined period of time is less than a thresholdpacing amplitude (e.g., 5 V) and set the pacing amplitude for pacingpulses delivered during the exposure operating mode equal to the highestpacing amplitude of the predetermined period of time when the highestpacing amplitude of the predetermined period of time is greater than orequal to the threshold pacing amplitude. The predetermined voltage andthe threshold pacing amplitude do not need to be the same value.

Alternatively, or additionally, processor 60 may analyze pacing pulsewidths during the predetermined period of time and select a pacing pulsewidth for the pacing pulses delivered during the exposure operating modebased on the analysis. For example, processor 60 may set the pacingpulse width for pacing pulses delivered during the exposure operatingmode to a predetermined width (e.g., 1 millisecond (ms)) when thehighest pacing pulse width during the predetermined period of time isless than a threshold pulse width (e.g., 1 ms) and set the pacing pulsewidth for pacing pulses delivered during the exposure operating modeequal to the highest pacing pulse width of the predetermined period oftime when the highest pacing pulse width of the predetermined period oftime is greater than or equal to the threshold pulse width. Thepredetermined pulse width and the threshold pulse width do not need tobe the same value.

When processor 60 selects a dual-chamber pacing mode for the exposureoperating mode, processor 60 may analyze PAV intervals during thepredetermined period of time and select a PAV interval for the exposureoperating mode based on the analysis. For example, processor 60 may setthe PAV interval for the exposure operating mode to a firstpredetermined interval (e.g., 110 ms) when the average PAV intervalduring the predetermined period of time is greater than or equal to afirst threshold PAV interval (e.g., 110 ms), set the PAV interval to theaverage PAV interval when the average PAV interval is less than thefirst PAV interval threshold and greater than or equal to a second PAVinterval threshold (e.g., 50 ms), and set the PAV interval to a secondpredetermined interval (e.g., 50 ms) when the average PAV interval isless than the second threshold PAV interval. The threshold PAV intervalsand the predetermined PAV intervals do not need to be the same values.

Processor 60 may also suspend some functionality, e.g., diagnostic andcounters, magnet mode, tachyarrhythmia and PVC detection,tachyarrhythmia therapies, or the like. A summary of an exampleautomatic determination criteria and the resulting selected parametersof the exposure operating mode is provided in Table 1 below. Table 1 isfor example purposes only and should not be considered limiting of thetechniques as broadly described in this disclosure. The variousthresholds and corresponding setting may be adjusted based on variousconsiderations.

TABLE 1 System Parameters Conditions Exposure Mode Settings Pacing ModePacing percentage <5% ODO 1) Pacing percentage ≥5% 2) Previousdual-chamber mode DOO 1) Pacing percentage ≥5% 2) Previous ventricularchamber mode VOO 1) Pacing percentage ≥5% 2) Previous atrial chambermode AOO Pacing Rate Avg Heart Rate ≤65 bpm 85 bpm Avg Heart Rate >65bpm 1.25 * Avg Heart Rate Pacing Amplitude Max Pacing Amplitude <5 V 5 VMax Pacing Amplitude ≥5 V Max Pacing Amplitude Pacing Pulse Width MaxPacing Pulse Width <1 ms 1 ms Max Pacing Pulse Width ≥1 ms Max PacingPulse Width PAV interval 1) Pacing mode = DOO 2) Avg PAV interval ≥110ms 110 ms 1) Pacing mode = DOO 2) 110 ms > Avg PAV interval ≥50 ms AvgPAV interval 1) Pacing mode = DOO 2) Avg PAV interval <50 ms 50 ms

Table 1 provides an example of the type of stored information that maybe used in selecting parameters of the exposure operating mode.Processor 60 may analyze other stored information in addition to orinstead of the system parameters described above. For example, processor60 may analyze pacing capture thresholds measured during thepredetermined period of time and select an amplitude and/or pulse widthfor pacing pulses to be delivered during the exposure operating modebased on the analysis. As another example, processor 60 may analyzemeasured sensing amplitudes during the predetermined period of time andselect one of a sensing threshold and/or pacing mode to used during theexposure operating mode based on the analysis. As a further example,processor 60 may analyze the arrhythmia episodes during thepredetermined period of time and select a pacing mode to be used duringthe exposure operating mode based on the analysis.

Processor 60 stores the automatically determined parameters of theexposure operating mode and uses at least a portion of the parameterswhen it is configured to operate in the exposure operating mode.Processor 60 may be configured to operate IMD 32 in the exposure mode atsome time prior to being exposed or immediately upon being exposed todisruptive energy field 11. In one instance, processor 60 may configureIMD 32 to operate in accordance with the automatically determinedparameters in response to detecting disruptive energy field 11. In thiscase, IMD 32 may be a fully automated MR Conditional or MR Safe devicethat does not require any manual programming of the exposure operatingmode parameters.

To this end, processor 60 may include one or more sensors, such as adisruptive field detector 68, that detect the presence of disruptiveenergy field 11. Disruptive field detector 68 may include a magneticfield detector, such as a Hall sensor or a reed switch. In someinstances, disruptive field detector 68 may be within housing 70 of IMD32. For example, disruptive field detector 68 may be the same fielddetector used to sense a magnetic programming head of a programmingdevice. Alternatively, IMD 32 may be coupled to a disruptive fielddetector 68 located outside of housing 70 of IMD 32.

Control processor 60 may receive one or more signals from disruptivefield detector 68. The signal produced by disruptive field detector 68may, for example, identify that patient 12 has entered an environment inwhich IMD 32 is exposed to an energy field, e.g., a magnetic field, thatis greater than or equal to a threshold level indicative of a disruptiveenergy field 11. In one example, processor 60 may utilize all or asubset of the detection methods described in U.S. Pat. No. 6,937,726 toTerry et al., entitled, “METHOD AND APPARATUS FOR DETECTING STATICMAGNETIC FIELDS,” which issued on Aug. 30, 2005 and which isincorporated herein by reference in its entirety. However, otherdisruptive field detection methodologies may also be employed byprocessor 60 in other examples to detect the presence of disruptiveenergy field 11, which may in one example be the static magnetic fieldof MRI scanner 16, the gradient magnetic fields of MRI scanner 16, orthe RF fields of MRI scanner 16.

In another example, processor 60 may receive, e.g., via telemetry,parameters for the exposure operating mode from a physician, clinician,or other person. In some instances, processor 60 may have alreadyautomatically determined suggested parameters for the exposure operatingmode. In this case, processor 60 may compare the previously determinedparameters with the parameters that were received and alert thephysician if there are any differences and, in some instances,significant differences, between the two sets of parameters. In otherinstances, the manually entered parameters may not be different from theautomatically determined parameters at the time the parameters aremanually received from the physician, but may differ at a later periodof time, e.g., due to do a changing condition of a patient. If there arediscrepancies between the automatically determined parameters and themanually programmed parameters, IMD 32 may initiate an alert to patient12 and/or physician notifying them that the automatically determinedparameters differ from the manually programmed parameters. For example,processor 60 may cause telemetry module 70 to transmit an alert or othersignal, e.g., via access point 20, network 22 and one of computingdevices 26, to notify a physician, clinician or technician ofdiscrepancy. In this manner, the telemetry signal may function as thealert mechanism. IMD 32 may generate an alert perceptible to patient 12in addition to or instead of the alert to the physician. Alarm module 76may include alarm circuitry to provide an audible alert, a perceptiblemuscle vibration, muscle stimulation or other sensory stimulation tonotify the patient that an alert condition has been detected, e.g., adiscrepancy between the manually programmed and automatically determinedparameters.

Alternatively or additionally, IMD 32 may provide the automaticallydetermined parameters to the physician or clinician at the time of themanual programming. In other words, IMD 32 may recommend appropriateparameters for the exposure operating mode. Processor 60 may transmitthe automatically determined parameters to a programming device 18 (orremote computing device 26) for display to the physician or clinician.The physician, clinician or other user may review the recommendedparameters and accept the suggested parameters or adjust one or more ofthe suggested parameters.

In any case, IMD 32 may continue to automatically determine theparameters to ensure that a change in condition of patient 12 does notchange the recommended parameters of the exposure operating mode. Forexample, suppose a physician manually configures the parameters of theexposure operating mode to be a sensing-only mode (e.g., ODO). After themanual configuration of the exposure operating mode, patient 12 is pacedduring the normal operating mode such that the pacing percentage exceedsthe threshold pacing percentage. IMD 32 automatically determines, priorto the MRI scan, that the recommended parameters of the exposureoperating mode are a pacing mode instead of sense-only mode due to thefact that the pacing percentage threshold is exceeded. IMD 32 may notifythe physician of such a discrepancy. Alternatively, or additionally, IMD32 may notify the patient to revisit the physician prior to the scan. Inyet another embodiment, IMD 32 may simply override the manuallyprogrammed parameters with the automatically configured parameters,e.g., override the sensing-only mode by the appropriate pacing mode. Assuch, automatically determining the parameters of the exposure operatingmode provides an added safety mechanism in case the condition of thepatient changes from the time between the manual programming of theparameters of the exposure operating mode and the MRI scan. Similaralerts or overriding changes may occur with respect to other exposureoperating mode parameters, such as pacing pulse amplitude, pacing pulsewidth, pacing rate, PAV interval or the like. In this manner, IMD 32 maycontinue to update the parameters of the exposure operating mode untiljust before exposure to disruptive energy field 11.

In some instances, processor 60 may determine whether to override theparameters or notify the patient and/or physician based on thedifferences. For example, processor 60 may override the parameters ininstances in which the difference does not represent a major difference,e.g., a slight change in pulse amplitude, pulse width or pacing rate.However, processor 60 may not override the differing parameters when thechange may be viewed as major, e.g., changing from a pacing-only mode toa sense-only mode or the like.

IMD 32 may revert back to the normal operating mode after exitingenvironment 10. For example, IMD 32 may be manually configured from theexposure operating mode to the normal operating mode using programmingdevice 18 or remotely via network 22. As another example, IMD 32 mayautomatically configure itself from the exposure operating mode to thenormal operating mode after determining that IMD 32 has exitedenvironment 10, e.g., in response to disruptive energy field detector 68no longer detecting disruptive energy field 11. As a further example,IMD 32 may automatically configure itself from the exposure operatingmode to the normal operating mode after a predetermined period of timeexpires. In response to detecting a disruptive energy field, it isdesirable that processor 60 be reconfigured from the exposure operatingmode to the normal operating mode as soon as safely possible afterexiting from environment 10, e.g., due to the reduced or otherwisedifferent functionality of the exposure mode. The techniques of thisdisclosure may be used to automatically revert processor 60 back to thenormal operating mode when particular criteria that are indicative ofthe MRI being complete occur.

FIG. 5 is a flow diagram illustrating example operation of an IMD, suchas IMD 14 or 32, in accordance with one aspect of this disclosure.Initially, processor 60 automatically determines at least a portion ofthe parameters and, in some instances all of the parameters, of theexposure operating mode (80). As described above, processor 60 mayperiodically determine the parameters of the exposure operating mode,e.g., every hour, two hours, four hours or the like. In automaticallydetermining the parameters of the exposure operating mode, processor 60may analyze any of a variety of stored information related to sensedphysiological events and/or therapy provided over a predetermined periodof time, including, but not limited to pacing modes in which the deviceoperated, percentage of time during which therapy is provided,amplitudes of the therapy energy delivered, pulse widths of the therapyenergy delivered, rate at which the therapy energy was delivered,average heart rate, peak heart rate, PAV intervals, pacing capturethresholds (e.g., rheobase and chronaxie), sensing amplitudes,arrhythmias or the like. Processor 60 stores the automaticallydetermined parameters in memory 72 or other storage mechanism (82).

Processor 60 determines whether IMD 32 is exposed to disruptive energyfield 11 (84). Control processor 60 may, for example, receive one ormore signals from disruptive field detector 68 indicating that patient12 has entered an environment in which IMD 32 is exposed to disruptiveenergy field 11, which may in one example be the static magnetic fieldof MRI scanner 16, the gradient magnetic fields of MRI scanner 16, orthe RF fields of MRI scanner 16. When processor 60 determines that IMD32 is not exposed to disruptive energy field 11 (“NO” branch of 84),processor 60 continues to automatically determine parameters of theexposure operating mode.

When processor 60 determines that IMD 32 is exposed to the disruptiveenergy field 11 (“YES” branch of 84), e.g., in response to receiving asignal from disruptive energy field detector 68, processor 60 retrievesthe automatically determined parameters of the exposure operating modefrom memory 72 (86) and configures IMD 32 in accordance with theretrieved parameters (88). In this case, IMD 32 may be a fully automatedMR Conditional or MR Safe device that does not require any manualprogramming of the exposure operating mode parameters.

FIG. 6 is a flow diagram illustrating example operation of an IMD, suchas IMD 14 or 32, in accordance with another aspect of this disclosure.Processor 60 receives, e.g., via telemetry, parameters for the exposureoperating mode from a physician, clinician, or other user of an externaldevice (90). In other words, the user of the external device manuallyprograms the parameters of the exposure operating mode.

Processor 60 determines whether IMD 32 is exposed to disruptive energyfield 11 (102). Control processor 60 may, for example, receive one ormore signals from disruptive field detector 68 indicating that patient12 has entered an environment in which IMD 32 is exposed to disruptiveenergy field 11, which may in one example be the static magnetic fieldof MRI scanner 16, the gradient magnetic fields of MRI scanner 16, orthe RF fields of MRI scanner 16. When processor 60 determines that IMD32 is exposed to the disruptive energy field 11 (“YES” branch of 102),e.g., in response to receiving a signal from disruptive energy fielddetector 68, processor 60 retrieves the parameters of the exposureoperating mode from memory 72 (104) and configures IMD 32 in accordancewith the retrieved parameters (106).

When processor 60 determines that IMD 32 is not exposed to disruptiveenergy field 11 (“NO” branch of 102), processor 60 automaticallydetermines parameters of the exposure operating mode using storedinformation regarding sensed physiological events and/or deliveredtherapies (92). In one instance, processor 60 may automaticallydetermine the parameters of the exposure operating mode prior toreceiving the manually programmed parameters from the external device.In this case, processor 60 may recommend a set of parameters for theexposure operating mode to the user via the external device to assistthe user in determining the parameters to manually program. Thephysician, clinician or other user may review the recommended parametersand accept the suggested parameters or adjust one or more of thesuggested parameters. In other instances, processor 60 may begin toautomatically determine the parameters of the exposure operating modeafter receiving the manually programmed parameters.

Processor 60 compares the manually programmed parameters received fromthe user to the automatically determined parameters (94). Thedifferences between the parameters may be differences in operating modes(e.g., sensing-only mode vs. pacing mode), differences in pacingparameters (e.g., pacing pulse amplitude, pacing pulse width, pacingrate, PAV interval) or other differences.

If there are no significant differences (“NO” branch of 96), processor60 continues to determine whether the IMD is exposed to disruptiveenergy field 11. If there are significant differences between theautomatically determined parameters and the manually programmedparameters (“YES” branch of 96), processor 60 may override the manuallyprogrammed parameters with the automatically determined parameters (98).IMD 32 may also provide a notification to alert patient 12 and/orphysician that the most recent automatically determined parametersdiffer from the manually programmed parameters (100). For example,processor 60 may cause telemetry module 70 to transmit an alert or othersignal to programming device 18 or one of the computing devices 26 tonotify the physician of discrepancy, or generate an alert perceptible topatient 12 in addition to or instead of the alert to the physician. Inresponse to the alert, patient 12 may revisit the physician or thephysician may remotely approve replacing the manually programmedparameters with the automatically generated parameters. Althoughdescribed as performing the automatic override and patient/physicianalert, processor 60 may only override, only alert or perform some othercompletely different action. Additionally, the actions are described asbeing performed when there are “significant” differences. However,similar techniques may be used for any differences, whether significantor non-significant.

In this manner, IMD 32 may continue to update the parameters of theexposure operating mode until just before exposure to disruptive energyfield 11 thereby providing an added safety mechanism in case thecondition of the patient changes from the time between the manualprogramming of the parameters of the exposure operating mode and the MRIscan.

FIG. 7 is a flow diagram illustrating example operation of an IMD, suchas IMD 14 or 32, automatically determining parameters of the exposureoperating mode in accordance with one aspect of this disclosure.Processor 60 of IMD 32 computes a pacing percentage (%) over apredetermined period of time (e.g., 1-4 hours) (110). The pacingpercentage may be computed by dividing the number of cardiac cyclesduring which a pacing pulse was delivered during the predetermined timeby the total number of cardiac cycles during the predetermined period oftime. Processor 60 compares the computed pacing percentage to athreshold pacing percentage (PP_(TH)) (112). If the pacing percentage isless than a threshold pacing percentage (“NO” branch of 112), processor60 selects a sense-only operating mode as the exposure operating mode(114). Because there is no pacing in these operating modes, suchoperating modes may prevent processor 60 from delivering undesirablestimulation or withholding desirable stimulation.

If the pacing percentage is greater than or equal to the thresholdpacing percentage (“YES” branch of 112), processor 60 analyzes theoperating modes in which IMD 32 operated during the predetermined periodof time to determine if IMD 32 operated in a dual-chamber pacing mode(116). If IMD 32 operated in any dual-chamber mode during thepredetermined time period (“YES” branch of 116), processor 60 selects adual-chamber pacing mode (122). The dual-chamber pacing mode may or maynot include sensing, but is not responsive to the sensing.

When processor 60 selects a dual-chamber pacing mode, processor 60 mayanalyze PAV intervals during the predetermined period of time and selecta PAV interval for the dual-chamber pacing mode based on the analysis.In the example illustrated in FIG. 7, processor 60 compares the averagePAV interval during the predetermined time to a first PAV intervalthreshold (PAV_(TH1)) (124). When the average PAV interval is greaterthan or equal to the first PAV interval threshold (“YES” branch of 124),processor 60 sets the PAV interval for the exposure operating mode to afirst predetermined PAV interval value (PAV₁) (126). When the averagePAV interval is less than the first PAV interval threshold (“NO” branchof 124), processor 60 compares the average PAV interval during thepredetermined time to a second PAV interval threshold (PAV_(TH2)) (128).When the average PAV interval is less than the second PAV intervalthreshold (“YES” branch of 128), processor 60 sets the PAV interval forthe exposure operating mode to a second predetermined PAV interval value(PAV₂) (130). When the average PAV interval is greater than or equal tothe second PAV interval threshold (“NO” branch of 128), processor 60sets the PAV interval for the exposure operating mode to the average PAVinterval during the predetermined period of time (132).

If IMD 32 has not operated in any dual-chamber mode during thepredetermined time period (“NO” branch of 116), processor 60 determineswhether IMD 32 operated in a ventricular-chamber pacing mode during thepredetermined period of time (118). If IMD 32 operated in anyventricular-chamber pacing mode during the predetermined time period(“YES” branch of 118), processor 60 selects a ventricular-chamber pacingmode (120). If IMD 32 has not operated in any ventricular-chamber pacingmode during the predetermined time period (“NO” branch of 118),processor 60 selects an atrial-chamber pacing mode (121). Theventricular-chamber pacing mode or the atrial-chamber pacing mode may ormay not include sensing, but are not responsive to the sensing.

Processor 60 may also determine one or more parameters of the selectedpacing mode based on the stored information. In the example illustratedin FIG. 7, processor 60 computes an average heart rate over thepredetermined period of time (134) and compares the average heart rateto a threshold heart rate (HR_(TH)) (136). When the average heart rateis less than or equal to the threshold heart rate (“YES” branch of 136),processor 60 sets the pacing rate for the selected pacing mode to apredetermined rate (HR₁) (e.g., 85 bpm) (138). When the average heartrate is greater than the threshold heart rate (“NO” branch of 136),processor 60 sets the pacing rate for the selected pacing mode to 1.25times the average heart rate (140).

Processor 60 compares the highest pacing amplitude during thepredetermined period of time to a threshold pacing amplitude (PA_(TH))(142). When the highest pacing amplitude during the predetermined periodof time is less than the threshold pacing amplitude (“YES” branch of142), processor 60 sets the pacing amplitude for pacing pulses deliveredduring the exposure operating mode to a predetermined pacing amplitude(PA₁) (144). When the highest pacing amplitude during the predeterminedperiod of time is greater than or equal to the threshold pacingamplitude (“NO” branch of 142), processor 60 sets the pacing amplitudefor pacing pulses delivered during the exposure operating mode to thehighest pacing amplitude that occurred during the predetermined periodof time (146).

Processor 60 compares the highest pacing pulse width during thepredetermined period of time to a threshold pacing pulse width (PW_(TH))(148). When the highest pacing pulse width during the predeterminedperiod of time is less than the threshold pacing pulse width (“YES”branch of 148), processor 60 sets the pacing pulse width for pacingpulses delivered during the exposure operating mode to a predeterminedpacing pulse width (PW₁) (150). When the highest pacing pulse widthduring the predetermined period of time is greater than or equal to thethreshold pacing pulse width (“NO” branch of 148), processor 60 sets thepacing pulse width for pacing pulses delivered during the exposureoperating mode to the highest pacing pulse width that occurred duringthe predetermined period of time (152).

The example illustrated in FIG. 7 is for example purposes only.Processor 60 may automatically determine only a portion of theparameters discussed and/or additional, different parameters. Moreover,processor 60 may also perform other actions in the exposure operatingmode. For example, IMD 32 may also suspend some functionality, e.g.,diagnostic and counters, magnet mode, tachyarrhythmia and PVC detection,tachyarrhythmia therapies, or the like. Some example threshold valuesare provided in Table 1 above for purposes of illustration. Table 1 isfor example purposes only and should not be considered limiting of thetechniques as broadly described in this disclosure. The variousthresholds and corresponding settings may be adjusted based on variousconsiderations.

FIG. 8 is a flow diagram illustrating example operation of an IMD, suchas IMD 14 or 32, recommending parameters for the exposure operating modein accordance with one aspect of this disclosure. Processor 60automatically determines at least a portion of the parameters and, insome instances all of the parameters, of the exposure operating mode(160). As described above, processor 60 may periodically determine theparameters of the exposure operating mode, e.g., every hour, two hours,four hours or the like. In automatically determining the parameters ofthe exposure operating mode, processor 60 may analyze any of a varietyof stored information related to sensed physiological events and/ortherapy provided over a predetermined period of time, including, but notlimited to pacing modes in which the device operated, percentage of timeduring which therapy is provided, amplitudes of the therapy energydelivered, pulse widths of the therapy energy delivered, rate at whichthe therapy energy was delivered, average heart rate, peak heart rate,PAV intervals, pacing capture thresholds (e.g., rheobase and chronaxie),sensing amplitudes, arrhythmias or the like. Processor 60 stores theautomatically determined parameters in memory 72 or other storagemechanism (162).

Processor 60 determines whether a user requests the automaticallygenerated parameters (164). For example, a user may request theparameters by interacting with a programming device 18 to transmit acommand requesting the automatically generated parameters. As anotherexample, the user may interact with a remote device, e.g., computingdevice 26, to transmit the command over network 22 to IMD 32. Whenprocessor 60 determines that the parameters were not requested (“NO”branch of 164), processor 60 continues to automatically determine theparameters of the exposure operating mode. When processor 60 determinesthat the parameters were requested (“YES” branch of 164), processor 60communicates the automatically determined parameters of the exposureoperating mode to the user (166). Processor 60 may cause telemetrymodule 70 to transmit a communication to a programming device 18 thatincludes the parameters and programming device 18 may display theparameters to the user. In this manner, IMD 32 may recommend parametersof the exposure operating mode to a user, e.g., a physician.

The techniques described in this disclosure, including those attributedto IMD 14 and/or 32, may be implemented, at least in part, in hardware,software, firmware or any combination thereof. For example, variousaspects of the techniques may be implemented within one or moreprocessors, including one or more microprocessors, DSPs, ASICs, FPGAs,or any other equivalent integrated or discrete logic circuitry, as wellas any combinations of such components, embodied in programmers, such asphysician or patient programmers, stimulators, or other devices. Theterm “processor” may generally refer to any of the foregoing circuitry,alone or in combination with other circuitry, or any other equivalentcircuitry.

Such hardware, software, or firmware may be implemented within the samedevice or within separate devices to support the various operations andfunctions described in this disclosure. In addition, any of thedescribed units, modules or components may be implemented together orseparately as discrete but interoperable logic devices. Depiction ofdifferent features as modules or units is intended to highlightdifferent functional aspects and does not necessarily imply that suchmodules or units must be realized by separate hardware or softwarecomponents. Rather, functionality associated with one or more modules orunits may be performed by separate hardware or software components, orintegrated within common or separate hardware or software components.

When implemented in software, the functionality ascribed to the systems,devices and techniques described in this disclosure may be embodied asinstructions on a computer-readable medium such as RAM, ROM, NVRAM,EEPROM, FLASH memory, magnetic data storage media, optical data storagemedia, or the like. The instructions may be executed to support one ormore aspects of the functionality described in this disclosure.

Various examples have been described. These and other examples arewithin the scope of the following claims.

1. A method comprising: automatically determining, with an implantablemedical device, one or more parameters of an exposure operating modebased on at least one of stored information related to sensedphysiological events and stored information related to therapy providedover a predetermined period of time; and switching operation of theimplantable medical device from parameters of a current operating modeto the one or more automatically determined parameters of the exposureoperating mode.
 2. The method of claim 1, wherein determining the one ormore parameters of the exposure operating mode comprises periodicallydetermining the one or more parameters of the exposure operating modebased on the stored information.
 3. The method of claim 1, furthercomprising: receiving one or more parameters for the exposure operatingmode via telemetry; comparing the parameters received via telemetry tothe automatically determined parameters; and overriding the receivedparameters that are different than the automatically determinedparameters with the automatically determined parameters.
 4. The methodof claim 1, further comprising: receiving one or more parameters for theexposure operating mode via telemetry; comparing the parameters receivedvia telemetry to the automatically determined parameters; and generatingan alert when at least one of the received parameters is different thanthe automatically determined parameters.
 5. The method of claim 1,further comprising transmitting the one or more automatically determinedparameters to an external device for presentation to a user.
 6. Themethod of claim 1, wherein the stored information includes operatingmodes of a predetermined period of time, the method further comprising:automatically determines one or more parameters of an exposure operatingmode by analyzing pacing therapies provided during the predeterminedperiod of time; and selecting an operating mode to be used during theexposure mode based on the analysis.
 7. The method of claim 6, whereinselecting the operating mode to be used during the exposure operatingmode based on the analysis comprises: selecting a sense-only mode whenthe implantable medical device has provided less than a threshold amountof pacing therapy within the predetermined period of time; and selectinga pacing mode when the implantable medical device has provided athreshold amount of pacing therapy within the predetermined period oftime.
 8. The method of claim 1, wherein the stored information includespacing amplitudes of pacing therapies delivered during a predeterminedperiod of time, the method further comprising: automatically determinesone or more parameters of an exposure operating mode by analyzing pacingamplitudes of the pacing therapies delivered during the predeterminedperiod of time; and selecting an amplitude for pacing pulses to bedelivered during the exposure operating mode based on the analysis. 9.The method of claim 1, wherein the stored information includes pacingwidths of pacing pulses delivered during a predetermined period of time,the method further comprising: automatically determines one or moreparameters of an exposure operating mode by analyzing pacing widths ofthe pacing pulses delivered during the predetermined period of time; andselecting a width for pacing pulses to be delivered during the exposureoperating mode based on the analysis.
 10. The method of claim 1, whereinthe stored information includes heart rates during a predeterminedperiod of time, the method further comprising: automatically determinesone or more parameters of an exposure operating mode by analyzing theheart rates during the predetermined period of time; and selecting apacing rate of pacing pulses to be delivered during the exposureoperating mode based on the analysis.
 11. The method of claim 1, whereinthe predetermined period of time is less than approximately four hours.12. The method of claim 1, wherein the stored information includesmeasured pacing capture thresholds during a predetermined period oftime, the method further comprising: analyzing the pacing capturethresholds measured during the predetermined period of time; andselecting one of an amplitude and pulse width for pacing pulses to bedelivered during the exposure operating mode based on the analysis. 13.The method of claim 1, wherein the stored information includes measuredsensing amplitudes during a predetermined period of time, the methodfurther comprising: analyzing the sensing amplitudes measured during thepredetermined period of time; and selecting one of a sensing thresholdand pacing mode to used during the exposure operating mode based on theanalysis.
 14. The method of claim 1, wherein the stored informationincludes arrhythmia episodes during a predetermined period of time, themethod further comprising: analyzing the arrhythmia episodes during thepredetermined period of time; and selecting a pacing mode to be usedduring the exposure operating mode based on the analysis.
 15. The methodof claim 1, further comprising storing the automatically determinedparameters of the exposure operating mode in a memory.
 16. The method ofclaim 1, further comprising: detecting presence of one or more energyfields generated by a magnetic resonance imaging (MRI) device, whereinswitching operation of the implantable medical device comprisesswitching from parameters of the current operating mode to the one ormore automatically determined parameters of the exposure operating modein response to detecting of the presence of the one or more energyfields generated by the MRI device.